Author: cathy

As of July 3, the Food and Drug Administration (FDA) will have increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack or hold food should ensure strong record-keeping practices.
Under the current criteria of the Food Drug and & Cosmetics Act, the FDA may order the detention of human or animal food where there is credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals.
As of July 3, the rule is amended under the Food Safety Modernization Act (FSMA) providing greater authority to use detention as an enforcement method. The new rule changes the criteria to allow the FDA to order detention if there is reason to believe an article of food is adulterated or misbranded. Foods can be detained for 20 calendar days with a possible 10 calendar day extension if needed.
The goal of the administrative detention of foods is to protect public health and prevent potentially harmful products from being consumed or used. Detaining products where there is doubt concerning safety certainly can reduce risk. The decision making skills of those implementing administrative detention, combined with the ability of companies to create and maintain good records will determine if detention is used to appropriately protect health while avoiding unnecessary burdens, shipments delays and added costs.
The majority of FDA administrative detention decisions historically appear to have been appropriate. According to information published in the Federal Register, the FDA estimated up to 48% of detained imported foods may have been detained because time was needed to determine the facts, and the product was later released as acceptable. This implies 52% of detained imported food was not released after detention. In other words, after investigation, 52% of the detentions were justified. For the public, this implies a majority of the FDA administrative detentions rightfully protected public health concerns.
These estimates are based on imported product because the FDA has not used administrative detention for domestic foods. Other methods have been used, including voluntary recall, instituting a seizure action, or referring the matter to state authorities. The prior use of these other enforcement methods makes it difficult to predict how often the detention of domestic product may be used as of July 3. If future FDA detentions of domestic products are based on similar decision-making skills as those employed for imports, the same 48% rate of potentially unnecessary detentions may be the result. It should be a shared goal between industry and effective July 3, the FDA has Increased Administrative Detention Authority government to reduce that value to ensure the vast majority of detention actions are necessary and controls are effectively implemented.
The FDA indicates it is more likely to use administrative detention where this is the most effective enforcement tool available and where the use of or exposure to the product may cause temporary or reversible adverse health consequences.
This would be similar to a product potentially subject to a Class II recall. Detention decisions will be made on a case-by-case basis. The Federal Register indicates each circumstance is “fact-specific.” Recording, documenting and ensuring a solid audit trail of the facts accurately is essential to every eligible entity susceptible to such a detention. The amount of time and resources spent gathering the information necessary is a factor of how well the required audit trail has been maintained in order to release the product and save the headache and costs of being forced to keep the product from the market.
A concern for companies engaged in manufacturing or holding human or animal foods is that administrative detention actions no longer need to be justified by credible evidence. Rather, a “reason to believe” could cause potentially unnecessary product loss or shipment delays of wholesome, legal products. Where facts are missing or inappropriately recorded, FDA must act upon available information to form a reason to believe the product is or is not safe. The old adage “when in doubt throw it out” might be changed to “when in doubt, consider the use of enforcement tools.” If sufficient doubt in a product or process exists, actions should be considered by the responsible company before the FDA might do the same.
The FDA has no funds or means of reimbursement for a company facing product loss due to an administrative hold where product is later found to be wholesome. The solution to avoiding potentially unnecessary actions is to ensure case-by-case decisions are based on well -documented fact and not belief.
A thoroughly documented food safety system with validated preventive controls (a HACCP plan) is the best means to avoid unnecessary detention. This can only be achieved with appropriate training, organized record-keeping systems and process management to ensure consistent enforcement of policies. Companies should review their food safety plans or have a third party do so, paying specific attention to record-keeping to ensure communication of accurate and complete data. Electronic quality management systems are highly encouraged, based upon the potential for human error and costs associated with managing a system of manual controls.
When reviewing a data system, consider the following:

If an activity has an impact on food safety, it should be recorded. For example, lack of evidence of appropriate use of sanitizers combined with the presence of a strong odor could lead to “reason to believe” the product is adulterated.

The frequency of recorded events should be related to food safety and process stability.

Be prepared to consider the product or process from the time of an “out-of-limits” event back to the last acceptable check as unacceptable. For example, if a company checks temperature once per hour, all production for up to one hour could be suspect if the process is discovered to be out of limits. If the same checks are once per shift, up to eight hours of production would be suspect. Records are to be completed in ink or signified electronically (21 CFR part 11 compliant) at the time of the event, and by the person conducting the activity.

Each recorded activity should include either affirmative or negative results accompanied by the signature or initials of the person who completed the action. Don’t only record noncompliance. Record evidence of compliance or control as well. For example, a daily sanitation inspection should document acceptable conditions as well as any unacceptable ones.

Following a corrective action always document a return to control or appropriate conditions.

For example, documentation of unacceptable sanitation should be followed by documentation of re-cleaning and re-inspection including the results of that inspection.
These are some of the steps needed to ensure factual communication which will lead to appropriate decisions and decrease the risk and costs associated with production losses. A reason to believe a product is adulterated could arise from an anonymous call to the FDA reportable food registry, a simple observation or even a customer complaint. Companies need to be prepared to share validated documentation of product status to remove doubt wherever possible.
Administrative detention of foods can be an effective tool beginning this July, if facts support the decisions made. Manufacturers and others who store, distribute, import, or produce food can ensure this by using good record-keeping practices and adopt quality systems and technologies that enable such practices to be enforced and embraced.
Contact the Authors:Cathy Crawford, Vice President, HACCP Consulting Group, L.L.C.
Cathy@foodsafety1.com | 757.371.5832 | www.haccpcg.com
Ms. Crawford has a broad range of experience in consulting, food manufacturing and food chemistry/microbiology laboratories. She is an enthusiastic trainer who has provided HACCP and other food safety training to a wide variety of businesses, including meat and poultry processors, bakeries, fruit and vegetable processors/packers, and food service establishments. She is a registered auditor for Safe Quality Foods (SQF). Ms. Crawford holds a master’s degree in food safety from Michigan State and a bachelor’s degree in biology from Arizona State University.James Dobbs, Qualtrax, Inc.
jdobbs@qualtrax.com | 540.382.4234 x103 | www.qualtrax.com

Although the final language for the food safety regulations are far from complete, it’s important for food companies to take note that the Act will likely have an impact in 2011. Prudent companies will begin their response this year, rather than waiting and facing potential consequences.At The HACCP Consulting Group, (HCG) we believe there are two areas of immediate interest for food companies. These areas are (1) the requirement for risk based food safety plans and (2) the new authority for mandatory recalls. To be prepared, in 2011, food companies should focus on the establishment of a risk based food safety (HACCP) plan, ensuring a strong recall plan, and flawless food safety record keeping.The area of greatest potential impact will be the requirement for a risk based food safety plan. Although the language of the Act does not specifically name Hazard Analysis and Critical Control Points (HACCP), HCG believes a HACCP Plan is the best, proven method to ensure food safety. In order to develop and implement a successful HACCP-based food safety system, it is essential to have properly trained personnel.
The second important requirement of the act will give the FDA authority to recall potentially hazardous products. While there are relatively few historical cases of companies refusing to recall suspect products in commerce, the Act will allow FDA to require a recall when there is sufficient evidence of a risk to the public. This implies two things for food companies. First is the importance of having a recall plan. A recall plan is more than the ability to trace food and packaging. A recall plan includes how to swiftly contact customers, remove food from commerce and destroy or recondition the product. When a recall takes place, actions must be swift. Companies that don’t have solid plans with internal and external communication systems, product control mechanisms and alternate transport or storage capabilities may face steeper expenses and an extended recall. Companies that are well prepared can minimize the financial, marketing and public food safety impacts of a recall.
Another area where improvements are needed comes from the fact that the act gives the FDA expanded authority to inspect records related to food. This will drive an immediate need for improving record keeping. A recall is an unfortunate and necessary action when errors are made or unexpected hazards are discovered. However, a recall may be required when product is suspect and cannot be proven safe through good records. This does not mean the product itself is known to be unsafe. It means the company failed to keep records needed to prove the product is not adulterated. If product becomes suspect due to a complaint, a regulatory observation or a call to an FDA or other hotline, companies must be prepared to prove the status of suspect products. If this is not possible, a recall may be required at significant loss to the company. HCG expects an increase in recalls due to this factor. This can be avoided with better record keeping.
The HACCP Consulting Group promotes and offers practical and personalized services to assist clients maintain compliance with regulatory changes such as this new act. For information on HACCP courses, please contact us. We can provide on-site or public courses or refer you to an internet based introductory or refresher course. HCG also has available a generic recall program that can be adapted to your company’s needs. We do not believe in selling ‘canned’ programs. We work closely with our clients offering a starting point and custom tailoring it to an effective program. We also are developing an internet based course on good record keeping. Please watch for details in future HCG newsletters.

Cathy has over 15 years prior experience in consulting, food manufacturing, and food chemistry / microbiology laboratories. She was the Director of Regulatory & Technical Services for a privately owned meat and poultry processing company where she was responsible for regulatory compliance, developing food safety strategies, ensuring appropriate export programs, and coordinating recall responses when necessary.

Cathy has specialized in food defense programs. She was the instructor for a series of food defense workshops sponsored by the USDA Food Safety Inspection Service (FSIS). She also facilitated national focus group meetings, bringing together industry, trade association and FSIS representatives to produce new model voluntary food defense plans and FSIS Guidance Material.

Ms. Crawford is an enthusiastic trainer who has provided HACCP and other food safety training to a wide variety of businesses including meat and poultry processors, bakeries, fruit and vegetable processors/packers, and food service establishments. In addition to her contributions within the HACCP Consulting Group, she is also a Senior Consultant for the Quality Support Group and an adjunct instructor at the Culinary Institute of Virginia.

The proposed regulations which are part of the Food Safety Modernization Act include provisions for mandatory recalls. While in rare cases, such provisions could potentially be helpful where a company is reluctant to conduct a recall, the vast majority of recalls are not only voluntary and effective, but often go above and beyond what may soon be defined as “requirements.”